The objectives of this research proposal are to determine through clinical and laboratory studies the toxicity, immunological effects, efficacy mechanism of action and clinical role of chemically defined bacterial component immunotherapy in human malignant disease. These objectives will be approached by detailed clinical Phase I, II and III studies of purified components used as single agents. The particular agents included in this current study are: aqueous suspension of M. smegmatis CWS; M. smegmatis CWS plus trehalose mycolate (Ps) attracted to oil; and the Re glycolipid of Salmonella typhimurium. Phase I and II clinical studies of intravenous CWS and Re glycolipid will be done. Phase I studies will be done in patients with advanced lung cancer, sarcoma, melanoma and hypernephroma. Phase II studies will be done mainly in patients with malignant melanoma and hypernephroma. We have observed response in these patients and consider these dseases "indicator systems" of active immunotherapeutic agents. Concurrently, immune testing will be performed to define the immunological effects of these agents, and to attempt to identify patients who have a high probability of responding to these agents. Studies by us over the past two years have demonstrated the effectiveness of CWS/P3/oil used, intralesionally in the treatment of human malignant melanoma. In the current proposal, a randomized Phase III study between intralesion CWS/P3/oil and aqueous CWS in patients with malignant melanoma will be conducted. This study will define the necessity of the trehalose mycolate (P3) and oil in the vaccine and provide additional data relative to the mechanism of action of these materials.